Copper IUD Treatment Observation Study (CITROS)
Menorrhagia
About this trial
This is an interventional treatment trial for Menorrhagia focused on measuring IUD, naproxen, bleeding
Eligibility Criteria
Inclusion Criteria:
• Age ≥ 18 and < 49 years. We are including a wide range of ages because women of all ages request TCu380A. While we recognize that some women approaching menopause (median age = 51.4 years) may have changes in their baseline menstruation, we trust that clinicians enrolling the patients into the study will ensure that these women meet all inclusion (i.e., regular cycles) and exclusion criteria (i.e., do not have diagnosis of menorrhagia).
- Requesting to have TCu380A IUD inserted as contraceptive method.
- English-speaking.
- Regular menstrual cycles ranging 21-35 days apart.
- Generally healthy.
- Willing to attend a 4- to 6-week follow-up visit and complete surveys.
Exclusion Criteria:
Known or suspected pregnancy.
- Contraindications to NSAID use. This includes underlying heart failure, chronic renal disease, chronic liver disease, peptic ulcer disease, or history of upper gastrointestinal bleed, and allergy to NSAIDs.
- Current regular use of a NSAID.
- Unwilling to avoid use of NSAIDs (except for study medication) for the duration of the study.
- Current diagnosis of menorrhagia, metrorrhagia, symptomatic uterine fibroids, or endometrial polyps.
- Use of depot medroxyprogesterone acetate (DMPA) or levonorgestrel-releasing intrauterine device (LNG IUD) within the previous 3 months.
- Postpartum in the past 4 weeks. The average day in which non-breastfeeding postpartum women ovulate is 25 days after birth, indicating that menstrual cycles can resume after the 4th postpartum week.
- Existing medical condition for which placement of TCu380A IUD is a contraindication according to the Centers for Disease Control and Prevention Medical Eligibility Criteria (MEC 4 medical conditions; see Appendix A).
- Currently breastfeeding.
- Previous use of the TCu380A.
Sites / Locations
- John H Stroger Jr Hospital of Cook County
- Harborview Medical Center
- UW Neighborhood Clinic Northgate
- Hall Health Center
- University of Washington Medical Centers
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Treatment
placebo
This study arm includes naproxen as potential treatment for heavy or prolonged bleeding or dysmenorrhea may provide useful preliminary data for a larger, adequately powered placebo-controlled comparative trial testing additional promising treatments, such as tranexamic acid.
This study arm includes capsules that are exactly like the active treatment medication (naproxen), but there is no active treatment medication in these tablets.